MAUDE Adverse Event Report: B. BRAUN MELSUNGEN AG EASYPUMP; PUMP, INFUSION, ELASTOMERIC

Model Number 4540018-02

Device Problems Fracture (1260); Excess Flow or Over-Infusion (1311)

Patient Problems Nausea (1970); Foreign Body In Patient (2687)

Event Date 05/19/2020

Event Type  malfunction  

Manufacturer Narrative

This report has been identified as b.Braun medical inc.Internal report number (b)(4).The actual device involved in the reported incident was not returned for evaluation.Without the actual sample a thorough sample analysis could not be performed and no specific conclusions can be drawn.Review of the device history record performed for the reported lot number did not reveal any abnormalities or non-conformances of this nature.If additional pertinent information becomes available a follow-up report will be filed.

Event Description

As reported by user facility through mw5094648: patient was started on a flourouracil infusion with braun elastomeric 2 day pump (lot # 19e12ge561) on monday (b)(6) 2020.She came to have the pump disconnected on (b)(6) and reported that the pump was empty yesterday and she felt more nauseous than last time she received the infusion.Fda safety report # (b)(4).No reporter information provided.

Manufacturer Narrative

This report has been identified as b.Braun internal report number (b)(4): reviewed the device history record for batch number 20d05g8934 and there were no defect encountered during in process and final control inspection.Received 1 picture of used capillary hub of introcan safety 3 pur 20g 1.1x32mm-eu.From the observation on the received picture and based on customer description the used capillary hub have shorter length of the capillary.The tear off part of capillary cannot be seen in the pictures and the surface of the torn off areas was not visible.Since no sample was returned, investigation will be conducted based on photo received.The in-line test equipment is subject of a frequent calibration and a regular verification related to its proper function.Herewith potential malfunctions of the systems would be detected in-time and would be mitigated.Beside the automated 100% in-line test equipment, independent in-process quality controls and final controls on a random sample basis will be conducted by different teams on a regular basis within the production process.Herewith a systematic product defect would be detected.Tear off capillary most likely not appear to be attributed by manufacturing process as the defect is able to be detected and rejected by the in-line vision system.Damages induced after assembly process is not possible since the catheter had been protected with protective cap.Based on the investigation above and from the customer description, this defect is believed to be caused possibly by reinserting the cannula into capillary which lead to the capillary being pierced and later got tear off during withdrawal.As communicated in ifu, warning section stated that: after withdrawal, do not reintroduce the steel needle into the catheter, as the latter may be cut off, leading to catheter embolism.The complaint could not be confirmed.

• Brand Name: EASYPUMP
• Type of Device: PUMP, INFUSION, ELASTOMERIC
• Manufacturer (Section D): B. BRAUN MELSUNGEN AG; carl-braun-str. 1; melsungen, hessen 34212 ; GM 34212
• MDR Report Key: 10195418
• MDR Text Key: 199118189
• Report Number: 9610825-2020-00119
• Device Sequence Number: 1
• Product Code: MEB
• UDI-Device Identifier: 04046964448638
• UDI-Public: (01)04046964448638
• Combination Product (y/n): N
• PMA/PMN Number: K081905
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 05/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 4540018-02
• Device Catalogue Number: 4540018-02
• Device Lot Number: 19E12GE561
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/08/2020
• Initial Date FDA Received: 06/25/2020
• Supplement Dates Manufacturer Received: 06/08/2020
• Supplement Dates FDA Received: 05/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1